MVC-Fluoride 0.25 mg

General Statements: All Other Content

SCI Developing Good Science into Great Medicine

Formula re: Contains

Multivitamin with Fluoride Chewable Tablets

Formulation re: Does NOT Contain

NO DYES, ARTIFICIAL FLAVORS OR SUGAR SACCHARIN AND GLUTEN FREE

Formula re: Contains

CONTAINS XYLITOL

General Statements: All Other Content

Made in U.S.A.

General Statements: All Other Content

Description Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "1" on the other.

General: Product/Version Code

rev. 11/18/11

Formula re: Contains

Inactive Ingredients Ingredient Name Strength Xylitol Cellulose, Microcrystalline Mannitol Talc Magnesium Stearate Talc Sucralose Citric Acid Monohydrate

General Statements: All Other Content

Product Characteristics Color WHITE (Off white to pale yellow) Score no score Shape ROUND Size 13mm Flavor FRUIT Imprint Code SCI:1 Contains

General Statements: All Other Content

Packaging # Item Code Package Description Mutlilevel Packaging 1 NDC:44945-1020-5 90 TABLET, CHEWABLE (TABLET) in 1 BOTTLE None

General Statements: All Other Content

Rx Only

General Statements: All Other Content

0.25 MG

Formula re: Contains

MVC-FLUORIDE (sodium fluoride, vitamin a, ascorbic acid, vitamin d, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin) tablet, chewable [Sancilio & Company Inc.]

General Statements: All Other Content

PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

Formula re: Contains

Active Ingredients/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Sodium Fluoride 0.25 mg Vitamin A (Vitamin A) Vitamin A 2500 [IU] Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg Vitamin D (Vitamin D) Vitamin D 400 [IU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 15 [IU] Thiamine (Thiamine) Thiamine 1.05 mg Riboflavin (Riboflavin) Riboflavin 1.2 mg Niacin (Niacin) Niacin 13.5 mg Pyridoxine (Pyridoxine) Pyridoxine 1.05 mg Folic Acid (Folic Acid) Folic Acid 0.3 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 4.5 mg

FDA Disclaimer Statement

NOTE: THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA.

Precautions re: All Other

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

Suggested/Recommended/Usage/Directions

Directions: USE AS DIRECTED BY YOUR PHYSICIAN.

General Statements: All Other Content

Description: Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and " 1" on the other.

Precautions re: Allergies

Caution: Do not use this product if you are allergic to any of the ingredients.

Precautions re: All Other

Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Precautions re: Children

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

Precautions re: Children

TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOCKING.

General Statements: All Other Content

This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

Precautions re: Allergies

CONTAINS XYLITOL

Storage

Storage: Store in a cool, dry place at room temperature 20(0) - 25(0)C (68(0) - 77(0)F) away from heat and sunlight. Store in original container.

Precautions re: All Other

IF OVERDOSE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATLEY 1-800-222-1222